General: Phenytoin capsules and solution for injection are formulated with the sodium salt of phenytoin. The free acid form of phenytoin is used in the phenytoin suspension 125 mg/5 mL. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa.
For all oral formulations, dosage should be individualized to provide maximum benefit. In some cases, serum drug level determinations may be necessary for optimal dosage adjustments. Optimum control without clinical signs of toxicity occurs more often with serum levels between 10 mcg/mL and 20 mcg/mL, although some mild cases of tonic-clonic (grand mal) epilepsy may be controlled with lower serum levels of phenytoin. With recommended dosage, a period of 7 to 10 days may be required to achieve steady-state serum levels with phenytoin, and changes in dosage (increase or decrease) should not be carried out at intervals shorter than 7 to 10 days.
Phenytoin oral suspension is not for parenteral use.
Adult Dosage for Seizures: Divided daily dosage: For oral capsules, patients who have received no previous treatment may be started on 300 mg daily, to be taken in three equally divided doses, and the dosage then adjusted to suit individual requirements. For most adults, the satisfactory maintenance dosage will be 300 mg to 400 mg daily, to be taken in three to four equally divided doses, respectively. An increase up to 600 mg daily may be made if necessary.
For the oral suspension, patients who have received no previous treatment may be started on 125 mg (5 mL) of the 125 mg/5 mL suspension three times daily, and the dosage then adjusted to suit individual requirements. An increase to 625 mg (25 mL) daily may be made if necessary.
Non-emergency oral loading dose in adult patients: An oral loading dose of phenytoin may be used for non-emergency initiation of therapy in adults who require rapid steady-state serum levels, and for whom intravenous administration is not desirable. This dosing regimen should be reserved for patients in a clinic or hospital setting where phenytoin serum levels can be closely monitored. Patients with a history of renal or liver disease should not receive the oral loading dose regimen.
The recommended oral loading dose is 1 g of phenytoin divided into three doses (400 mg, 300 mg, and 300 mg) and administered at 2-hour intervals. Normal maintenance dosage is then instituted 24 hours after the loading dose, with frequent serum level determinations.
Pediatric Dosage for Seizures: For oral capsules, initially 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 mg/kg to 8 mg/kg. Children over 6 years and adolescents may require the minimum adult dose (300 mg/day). If the daily dosage cannot be divided equally, the larger dose should be given at bedtime.
For the oral suspension, initially 5 mg/kg/day in two or three equally divided doses with subsequent dosage individualized to a maximum of 300 mg daily. A recommended daily maintenance dosage is usually 4 mg/kg to 8 mg/kg. Children over 6 years and adolescents may require the minimum adult dose (300 mg/day).
Dosing in Special Populations: Patients with Renal or Hepatic Disease: see Precautions.
Elderly Patients: Phenytoin clearance is decreased slightly in elderly patients and lower or less frequent dosing may be required (see Pharmacology: Pharmacokinetics: Special Populations: Age under Actions).
Other Services
Country
Account